Study on the Effect of Adding Thoracic Radiotherapy to Durvalumab and Chemotherapy for Patients with Extensive Stage Small-Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as extensive stage small-cell lung cancer. The trial is investigating whether adding a type of radiation treatment to a combination of medications can help patients live longer. The medications being used in this study include durvalumab, also known by its code name MEDI4736, which is a type of immunotherapy. Immunotherapy is a treatment that helps the body’s immune system fight cancer. This study also involves chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of the study is to find out if combining radiation therapy with durvalumab and chemotherapy can improve the survival rate of patients with this type of lung cancer. Participants in the study will receive these treatments, and some may receive a placebo instead of the active medication. The study will monitor the participants over time to see how well the treatments work and to check for any side effects. The study aims to understand the benefits of this combined treatment approach over a period of several years.

Throughout the study, researchers will look at various outcomes, such as how long patients live after starting the treatment and how the cancer responds to the treatment. They will also assess the quality of life of the participants and any side effects they experience. This information will help determine if the addition of radiation therapy to the existing treatment plan can provide a significant benefit to patients with extensive stage small-cell lung cancer.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding and agreeing to the study’s requirements and restrictions.

Eligibility is confirmed based on specific criteria, including age, health status, and lung cancer stage.

2 initial assessment

An initial assessment is conducted to evaluate lung function and overall health. This includes tests like pulmonary function tests and imaging scans such as CT or MRI.

The presence of at least one lesion in the thorax that can be treated is confirmed.

3 treatment phase

The treatment involves the administration of durvalumab, an immunotherapy drug, given intravenously. The specific dosage and frequency are determined by the study protocol.

Chemotherapy is administered alongside durvalumab. The exact drugs and schedule are specified in the study protocol.

Thoracic radiotherapy is added to the treatment regimen. This involves targeted radiation to the chest area.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health status and response to treatment. This includes physical examinations and imaging tests.

The frequency and severity of any side effects are recorded and managed as necessary.

5 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation is conducted to assess the overall response to the therapy.

Long-term follow-up may continue to monitor survival rates and quality of life over several years.

Who Can Join the Study?

Must be able to give signed informed consent, which means agreeing to the study’s rules and procedures.
Have Stage IV disease according to the TNM v8 system. Patients with Stage III disease can join if the disease is too widespread to be treated as limited stage small-cell lung cancer (SCLC).
Have good lung function, with FEV1 (a measure of how much air you can forcefully exhale in one second) greater than 1 liter or more than 30% of the predicted value, and DLCO (a test that measures how well your lungs transfer gas) greater than 30% of the predicted value.
Female patients who can have children should use highly effective birth control and avoid pregnancy during the study and for at least 5 months after the last dose.
Patients with brain metastases (cancer that has spread to the brain) can join if they have no symptoms or are stable on steroids and/or anticonvulsants before starting treatment.
Must be at least 18 years old at the time of joining the study.
Have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Body weight must be more than 30 kg (about 66 pounds).
Have adequate organ and bone marrow function, meaning the organs and bone marrow are working well enough.
Must be willing and able to follow the study’s rules, including attending treatment sessions, scheduled visits, exams, and follow-up.
Have a life expectancy of at least 3 months.
Have at least one lesion (abnormal tissue) in the chest area that hasn’t been treated with radiation before and can be treated with radiation to 30 Gy in 10 sessions. A CT scan or MRI must be done within 28 days before starting the study to assess the tumor.
Have a confirmed diagnosis of small-cell lung cancer (SCLC) through a histological (study of tissue) or cytological (study of cells) test. Mixed types of cancer may be allowed if more than 90% is SCLC.

Who Cannot Join the Study?

Patients with any other type of cancer besides small-cell lung cancer, extensive stage cannot participate. This means the study is only for those with this specific type of lung cancer.
Patients who have had previous treatment with durvalumab or similar medications are not eligible. Durvalumab is a type of medicine used to help the immune system fight cancer.
Patients with serious heart problems are excluded. This includes conditions like heart failure or recent heart attacks.
Patients with uncontrolled infections cannot join. This means if an infection is not being managed well with treatment, the patient cannot participate.
Patients with severe liver or kidney disease are not eligible. This refers to serious problems with these organs that affect their normal function.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 4 weeks are excluded. This is to ensure that previous treatments do not affect the study results.
Patients with known allergies to the study medications are not eligible. This means if a patient has had a bad reaction to similar drugs before, they cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Nordlandssykehuset HF	Bodo	Norway
Lund University Hospital	Lund	Sweden
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Karolinska University Hospital	Solna	Sweden
Vestre Viken HF	Drammen	Norway
Sykehuset Innlandet HF	Brumunddal	Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
North Estonia Medical Centre Foundation	Tallin	Estonia
Sykehuset I Vestfold HF	Tonsberg	Norway
Hvhxm Fzczf Ha	Haugesund	Norway
Hmsxt Nndwmfekeaibyc Hq	Levanger	Norway
Azxvzoan Uaaablmobc Hkzuhmmg	Lorenskog	Norway
Usmlbdj Uyiabppesx Hfiahxuw	Uppsala	Sweden
Hokib Bfmxub He	Bergen	Norway
Eetetjf Udsdxfmqbjsk Mqvbfyw Ceyyjob Raprdmtja (gulieml Mgx	Rotterdam	The Netherlands
Hkciz Mlxoo Ou Riewwod Hz	Aalesund	Norway

Trial status

Country	Status	Recruitment Start
Estonia	Not recruiting	01.08.2023
Iceland	Not recruiting	01.08.2023
Norway	Not recruiting	01.08.2023
Sweden	Not recruiting	01.08.2023
The Netherlands	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Durvalumab

Durvalumab is an immunotherapy medication used in this trial. It helps the body’s immune system to detect and fight cancer cells more effectively. It is being tested to see if it can improve survival rates in patients with extensive stage small-cell lung cancer when combined with other treatments.

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is used alongside durvalumab to see if the combination can improve the survival of patients with extensive stage small-cell lung cancer.

Thoracic Radiotherapy (TRT) is a treatment that uses high-energy rays to target and kill cancer cells in the chest area. This trial is investigating whether adding thoracic radiotherapy to the combination of durvalumab and chemotherapy can further improve the survival rates of patients with extensive stage small-cell lung cancer.

Investigated diseases:

Small cell lung cancer extensive stage

Small-cell lung cancer, extensive stage – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called “extensive stage” when the cancer has spread beyond the lungs to other parts of the body. The disease progresses rapidly, often involving the liver, bones, and brain. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to weight loss and fatigue. The rapid growth and spread make it a challenging condition to manage.

Trial ID:

2023-505514-15-00

NCT ID:

NCT05223647

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Adding Thoracic Radiotherapy to Durvalumab and Chemotherapy for Patients with Extensive Stage Small-Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?